A Randomized Double-blind, Placebo-controlled Japanese Phase III Trial of ARQ 197 in Hepatocellular Carcinoma (HCC)

Inclusion Criteria:

* Informed consent form
* ≥20 years old
* Inoperable HCC which is not eligible for locoregional therapy
* Diagnosed as c-Met high in tumor sample
* Radiographic progression is confirmed during or after systemic chemotherapy including sorafenib, or those who are intolerance to the chemotherapy.
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) is 0 or 1
* Child-Pugh Class A
* Having measurable target lesions which are defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1,
* Negative pregnancy test results
* Adequate organ function
* Life expectancy of at least 12 weeks

Exclusion Criteria:

* More than 2 prior systemic chemotherapy.
* Prior therapy of c-Met inhibitor (including antibody)
* Any systemic therapy within ≤2 weeks prior to the randomization
* Locoregional therapy within ≤4 weeks prior to randomization.
* Major surgery within ≤4 weeks prior to the randomization
* Concurrent cancer within ≤5 years prior to the randomization
* History of cardiac diseases
* Active clinically serious infections defined as ≥ Grade 3 according to Common Toxicity Criteria for Adverse Effects (CTCAE) 4.0
* Any psychological disorder affecting Informed Consent
* Diagnosis positive for anti-HIV antibody and/or anti-HTLV-1 antibody
* Blood or albumin transfusion within ≤14 days prior to the screening test
* Concurrent interferon therapy against Hepatitis B Virus (HBV)/ Hepatitis C Virus (HCV)
* Symptomatic brain metastases
* History of liver transplantation
* Inability to swallow oral medications
* Confirmed interstitial lung disease
* Pleural effusion and/or clinically significant ascites
* Pregnancy or breast-feeding
* Without consent to effective single or combined contraceptive methods